Quote from VigiServe Admin on November 27, 2020, 2:26 PM

The pharmacovigilance (PV) system in **Singapore** is one of the most advanced and mature in Asia, fully aligned with international standards (ICH, WHO, and largely EU GVP principles), and managed by the **Health Sciences Authority (HSA)** under the **Health Products Act 2007** and **Health Products (Therapeutic Products) Regulations 2016**. HSA operates the **National Adverse Drug Reaction Monitoring Unit** (national PV centre), which collects ADRs/AEFIs, performs signal detection, causality assessment (using WHO-UMC method), risk evaluation, regulatory actions (alerts, label changes, recalls), and contributes to VigiBase (full WHO PIDM member since 1994). The system emphasizes electronic reporting, post-marketing surveillance, and risk-based enforcement.

**Legal Framework and Governance**
- **Health Products (Therapeutic Products) Regulations 2016** (Reg 23–25): Mandates PV obligations for registrants/MAHs.
- **Guidance on Pharmacovigilance for Therapeutic Products** (latest version 2024–2025, available on HSA website).
- HSA's **Medicines Regulation Division** oversees compliance, inspections, and safety communication.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/registrants must establish and maintain a PV system compliant with HSA guidance.
- **Local Contact Person for Pharmacovigilance**: Mandatory for foreign MAHs; a local representative in Singapore (often a Singapore-registered entity/agent) responsible for regulatory liaison and PV compliance (not a full resident QPPV requirement like EU).
- **Pharmacovigilance System Master File (PSMF)**: Not explicitly mandatory, but MAHs must maintain detailed PV system documentation (SOPs, procedures) available for HSA inspections.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- MAHs must report all suspected ADRs (serious/non-serious), medication errors, lack of efficacy, and quality defects to HSA via the **Vigilance Branch** (electronic preferred; portal available).
- **Timelines** (aligned with ICH):
- **Serious ICSRs** (unexpected or increased frequency/severity): Expedited within **15 calendar days** of receipt/awareness.
- **Non-serious ICSRs**: Within **90 calendar days** or periodic aggregates.
- Foreign serious unexpected ICSRs: **15 calendar days** if relevant to benefit-risk.
- MedDRA coding required; reports feed into HSA database and VigiBase.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- MAHs submit PSURs/PBRERs (ICH E2C(R2) format) to HSA.
- Frequency: Typically every **6 months** initially (first 2 years post-registration), then **annually** or as specified (aligned with ICH; evaluated by HSA during renewals/variations/safety concerns).

**Risk Management Plans (RMP)**
- Mandatory for new chemical entities, biologics, high-risk products, biosimilars, or specific concerns.
- EU-style format with Singapore-specific adaptations/annex (local implementation, justifications).
- Updates required for new risks or significant changes; HSA may impose additional risk minimization measures.

**Signal Management and Emerging Safety Issues**
- MAHs continuously monitor global/local data and notify HSA of validated signals or emerging concerns promptly.
- HSA leads national signal detection (using VigiLyze/tools) and risk assessment.

**Clinical Trials-Related Safety Requirements**
Clinical trials require HSA approval (Clinical Trial Notification [CTN] or Clinical Trial Certificate [CTC]; aligned with ICH GCP).
- Sponsors monitor safety and report to HSA's Clinical Trial Branch.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (ICH E2A-aligned):
- Fatal/life-threatening SUSARs: **7 calendar days**.
- Other serious unexpected SUSARs: **15 calendar days**.
- **Development Safety Update Reports (DSURs)**: Annual submission required (ICH E2F format), especially for ongoing trials.
- Reports via electronic portal (e.g., PRISM system); sponsor responsibility for monitoring, causality assessment, DSMB (if applicable), and communication to HSA/ethics committees/IRBs.
- Serious breaches of GCP/protocol must be reported promptly.

**Additional Monitoring / Other Aspects**
- No black triangle scheme, but **additional monitoring** may be imposed for new/high-risk products (e.g., biologics, vaccines).
- Emphasis on electronic reporting (HSA portal), HCP/patient submissions, and risk-based inspections.
- Post-marketing surveillance mandatory for new drugs (often 3–5 years or risk-based).
- Reporting volumes high relative to population; under-reporting addressed via awareness and training.

Singapore's PV framework is ICH/EU-harmonized, enforcement-oriented, and one of Asia's strongest (mandatory local contact, PSMF-like documentation, 15/90-day ICSR timelines, routine PSUR/RMP, expedited SUSAR/DSUR). It balances robust obligations with efficient approvals.

For precise, product- or trial-specific details (e.g., latest guidance versions, forms, or submission portals), consult **Health Sciences Authority (HSA)** directly via hsa.gov.sg (Therapeutic Products > Pharmacovigilance section, guidance documents, or contacts), as requirements evolve (e.g., 2025–2026 updates on electronic systems and risk management). Companies often appoint a local representative and align with HSA guidelines for compliance in Singapore.

Online Reporting

AE Reporting Form

Vaccine AE Form

Guidance for Industry_Post-marketing Vigilance Requirements for Therapeutic Products and CTGTP469 KB

Guidance for Industry_Post-marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (Aug 2024)

Report Via: Post: ​

Adverse Event Management Unit Vigilance Branch Health Sciences Authority Health Products Regulation Group 11 Biopolis Way #11-03, Helios Singapore 138667 ​

Tel: (65) 6866 1111 ​

E-Mail: HSA_productsafety@hsa.gov.sg ​

Fax: (65) 6478 9069

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